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The Benefits of Clinical Trials

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Aldige points out that clinical trials have a high degree of protection forpatients. Every trial is approved by the FDA to assure that the productbeing tested will be safe, and by an institutional review board, consistingof experts at the institution where the trial is taking place. The reviewboard, among other things, assures that patients receive theinformation they need to decide whether to participate.

A patient must sign an informed consent form to participate in a study. A good informed consent form will tell them what the therapy is for, whetherall patients will receive an active drug, what the possible or expectedbenefits are, and what the risks may be.

During clinical studies, extensive information is gatheredfrom the patients -- their disease or condition, how they react to thetreatment, and potential side effects, which will be monitored.

The health sections of newspapers are filled with advertisements forclinical trials, for everything from sleep disorders to depression to highcholesterol to menopausal symptoms. Drug investigators must advertise torecruit patients with the exact criteria they are seeking. Increasingly, the Internet is beingused for recruitment. The National Institutes of Health recently launched its own web page to listclinical trials and the medical criteria for entry:http://clinicaltrials.gov.

Aldige and other experts advise people with diseases that do not have fullyeffective treatments to explore -- through their physicians, newspapers, or the Internet -- the possibility of enrolling in clinicaltrials. Not only will these patients benefit, but the more people who enroll, themore quickly new therapies will become available for people who may need them in the future.

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